This funding opportunity announcment (FOA) issued by the
National Institute of Environmental Health Sciences (NIEHS), and the National
Science Foundation (NSF) solicits grant applications that address research
approaches to problems that are relevant to oceans and human health. The
purpose of Centers for Oceans and Human Health (COHH) is to provide linkages
between members of the ocean sciences and biomedical communities in order to
support interdisciplinary research in areas where improved understanding of
marine processes and systems has potential to reduce public health risks. This
FOA will solicit grant applications that address harmful algal bloom (HAB)
research, marine pollution (e.g., chemical toxicants assessment of long-term
chronic exposures versus acute exposures; aspects of global climate change
that influence ocean related human health outcomes; and development of
statistical and bioinformatic tools to link developed oceanographic models
with less well developed human health exposure and disease models). COHH
awards are expected to create an environment conducive to interdisciplinary
and reciprocally beneficial collaborations among biomedical scientists (e.g.,
epidemiologists, pharmacologists, toxicologists, microbiologists, cell and
molecular biologists) and ocean scientists (e.g., biological and physical
oceanographers, geochemists, and ecologists) with the common goal of
improving our knowledge of the impacts of the ocean on human health.

Key Dates

Posted Date

September 15, 2011

Letter of Intent Due Date

October 22, 2011

Application Due Date(s)

November 22, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

April 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 2012

Expiration Date

November 23, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

Oceans occupy greater than 70% of the planet’s surface and
60 % of the human population lives within 75 miles of coastal waterways or
ocean coasts. Thirteen out 15 of the world’s largest cities lay on or near
coasts and the proximity of human populations to ocean coasts is not surprising
when our past, current and future dependence on coastal waterways for food,
commerce, travel and recreation are taken into consideration. The largest
source of protein in the world is fish and more fish are harvested throughout
the world than cattle, sheep, poultry or eggs. Billions of dollars are turned
over annually from fishing, and other commercial ventures, which certainly
include travel and recreational use of coastal waterways. Human populations are
extremely dependent on the ocean for work, food, travel and recreation and many
aspects of health maintenance are also associated with the oceans. Consequently,
human activities can be associated with several point and non-point sources of
chemical pollutants and toxicants, draining into the oceans and coastal
waterways daily, as well as 2.8 billion tons of industrial waste being
released into the oceans annually by the US alone. This marine pollution
causes significant damage to marine ecology and has multiple potential negative
impacts on human health. It is clearly recognized that the oceans are a
sustaining, re-invigorating resource that demands proper stewardship because
our well being and health outcomes are at risk. Increasing marine temperatures
associated with global climate change introduces additional variables that may
further escalate human health risks associated with oceans.

In April 2004, the National Institute of Environmental
Health Sciences (NIEHS) and the National Science Foundation (NSF) (hereafter
"the Government" or "the Participating Agencies") announced
funding for four joint Centers for Oceans and Human Health. The Centers for
Oceans and Human Health (COHH) aimed to provide linkages between members of the
ocean sciences and biomedical communities in order to support interdisciplinary
research in areas where improved understanding of marine processes and systems
has potential to reduce public health risks and enhance existing biomedical
capabilities. These Centers were expected to create environments conducive to
interdisciplinary and reciprocally beneficial collaborations among biomedical
scientists (e.g., epidemiologists, pharmacologists, toxicologists,
microbiologists, cell and molecular biologists) and ocean scientists (e.g.,
biological and physical oceanographers, geochemists, and ecologists) with the
common goal of improving our knowledge of the impacts of the ocean on human
health. The NIEHS and the NSF support complementary sets of scientific
expertise and disciplines that were brought together to address/study a number
of human health effects that are directly related to oceans, the
micro-organisms that thrive in the oceans, climatic and geophysical oceanic
processes and pollution.

That solicitation, RFA-ES-03-003, drew on the recommendations contained in the strategic plans of the
Participating Agencies (NIEHS Strategic Plan 2000; NSF Geosciences Beyond 2000;
and Environmental Science and Engineering for the 21st Century: The Role of the
National Science Foundation); those highlighted by the Ocean Studies Board of
the National Research Council (From Monsoons to Microbes: Understanding the
Oceans Role in Human Health, National Academy Press, 1999); and those discussed
at a Government-sponsored Roundtable on Oceans and Human Health in Research
Triangle Park, NC, December, 2001.

This FOA presents an ongoing opportunity to continue the
development of this new paradigm for studying adverse relationships between the
oceans and human health. Research priorities identified in this OHH
solicitation include recommendations made by the National Science and
Technology (NCST) Joint Subcommittee on Ocean Science and Technology (JSOST)
report, Charting the Course for Ocean Science in the United States for the Next
Decade: An ocean research priorities plan and implementation strategy; and the
Interagency Oceans and Human Health Research Implementation Plan: A
Prescription for the Future by the Interagency Working Group on Harmful Algal
Blooms, Hypoxia, and Human Health (Sandifer, P., C. Sotka, D. Garrison, and V.
Fay. 2007); and The Interagency Oceans and Human Health Research Implementation
Plan: A Prescription for the Future, Interagency Working Group on Harmful Algal
Blooms, Hypoxia, and Human Health of the Joint Subcommittee on Ocean Science
and Technology. Washington, DC.

This FOA is soliciting applications that address: HAB
research; marine pollution (e.g., chemical toxicants); uses models or sentinels
in the assessment of long-term chronic exposures versus acute exposures; and
development of statistical and bioinformatic tools to link developed
oceanographic models with less well developed human health exposure and disease
models.

It is anticipated that COHH will be multidisciplinary
research programs in the diverse areas of oceanography, climatology, ecology,
biomedical science, and computational biology. These Centers will participate
in a national network of investigators and will foster an interconnected
research approach dedicated to understanding the physical, chemical, and
biological complexities linking oceans and human health.

Objectives

Investigators applying under this FOA may focus on one or
more of the suggested topics that link oceanographic sciences with human health
outcomes.

Harmful
algal blooms

Human health outcomes related to oceans have been documented
as far back as 800 B.C. when illness resulting from the consumption of
contaminated fish was recorded in Homer’s Odyssey. In present times, human
illnesses are still primarily caused by consumption of contaminated seafood but
are also caused by inhalation of aerosolized toxins. Each year in the United
States alone, over 60,000 cases of poisoning by exposure to harmful algal
blooms (HABs) are reported. HABs release marine toxins that are frequently
associated with fish kills, bird kills, and marine mammal kills. Adverse
health outcomes in humans range from acute neurotoxic disorders, such as
saxitoxin, brevetoxin, and ciguatera poisonings like paralytic shellfish
poisoning, neurotoxic shellfish poisoning and ciguatera finfish poisoning, to
more chronic diseases, e.g., chronic liver disease caused by microcystins and
amnesic shellfish poisoning from domoic acid exposure. Presently it is not
known what is responsible for or triggers outbursts of HABs. Methodologies for
early detection or remote sensing of outbreaks would provide a major mechanism
for reducing/preventing exposures to marine toxins released by HABs. This FOA
will support studies that address mechanisms of HAB toxin toxicity; elucidation
of toxin synthesis; and remote sensing and prediction of HAB events, including
approaches that utilize satellite data. Studies that apply high-throughput
genomic, proteomic, and metabolomic technologies in combination with measures
of sea surface temperature, sea surface salinity, stream flow, wind speed, and
or precipitation to address mechanisms of toxicity and remote sensing of HAB
events are encouraged.

Marine
pollution

Deep offshore oil drilling near the coastline of Louisiana
has produced one of the largest anthropogenic environmental disasters in
history. The massive spill in the Gulfof Mexico is the largest spill in the
history of the United States. Scientists have estimated that the recent oil
spill in the Gulf of Mexico maybe spewed as much 184 million
gallons of crude oil covering approximately 572 miles of Gulf Coast shoreline,
threatening fisheries, tourism, and the habitat of hundreds of bird species.
Additionally, over 1.8 million gallons of dispersant chemicals were released to
help break up the oil. The short term and long term chronic impacts and risks
to human health currently are not known, but clearly major oil spills resulting
from deep shore oil drilling operations can be a major source of chemical
pollution in the marine environment. There are multiple additional sources of
marine pollution that also may impact human health and ecological systems. These
include but are not limited the following: oil that is introduced into marine
environments via: routine machine maintenance; drainage; or natural seepage. There
are additional toxic materials introduced into marine environments via
agricultural runoff, which includes: runoff from barnyards; and runoff from
feedlots that includes pesticides and fertilizers. Additional sources of
marine pollution come from urban and industrial runoff. These sources include:
runoff from building and paved surfaces; storm water drainage; sewage;
automotive emissions and other air pollutants. Vast marine dumping and
removal/dredging procedures can result in marine contamination with: sewage
sediment, including domestic, municipal and industrial garbage; harbor/waterway
sediment; and pollution from industrial toxic by-products.

Climate
change and OHH

Global climate change has become one of the most visible
environmental concerns of the 21st century. Climate change will affect
ocean and coastal ecosystems through increasing temperatures, sea level rise,
changes in precipitation patterns, changes in ocean pH and salinity, and more
frequent and intense extreme weather events. Climate may also affect the
distribution and concentrations of chemical contaminants in coastal and ocean
waters, for example through release of chemical contaminants previously bound
up in polar ice sheets or sediments or through changes in volume and
composition of contamination runoff. As a result, many ocean-borne diseases,
including those described above, are expected to worsen. A better understanding
of how global warming will alter ocean-related human health risks and
vulnerabilities is needed. This FOA encourages research and methodical
development applications to help quantify and forecast ocean-related human
health threats under current and future climate scenarios.

HAB
Research: Examples of research topics to be addressed include,
but are not limited to:

Development of enhanced and or novel remote sensing and
prediction of HAB events utilizing oceanic, geological and atmospheric
measurements as well as retrospective analysis of satellite data;

Marine
Pollution: Examples of research topics to be addressed include,
but are not limited to:

Studies focusing on human health risks associated with marine
pollution from a number of sources, including but not limited to: agricultural
and or urban runoff; marine dumping, and major spills that affect ecological
systems and have demonstrable direct effects on human health outcomes;

Studies focusing on the mechanisms of toxicity of marine chemical
pollutants; and

Studies focusing on the relationships of transport and fate to
adverse human health outcomes.

Climate
Change and OHH: Examples of specific topics of interest
include, but are not limited to:

Studies to determine how climate directly and/or indirectly
impacts toxic algal blooms, including their initiation, development,
termination, and other characteristics that influence the occurrence and severity
of associated human disease;

Studies to evaluate health risks associated with climate-change
induced increases in the release and mobilization of chemical contaminants;

Studies to determine synergistic interactions among ocean-related
toxins, chemicals, and waterborne pathogens also likely to be impacted by
climate change, and how changes in climate will impact these relationships; and

Development of methods to detect, quantify and forecast
ocean-related health threats, including improved surveillance and monitoring of
disease-causing agents in coastal waters, marine organisms, aerosols,
sediments, and exposed human populations.

Development
of models and statistical and bioinformatic tools: Additionally,
this FOA encourages:

The development of statistical and bioinformatics tools that link
the developed oceanographic models with the less well developed human health
exposure and disease models;

Models or sentinnels(cetaceans) to use to examine chronic vs
acute exposures to predict adverse human health outcomes; and

Models to assess genetic susceptibility to marine toxicants based
on ability to metabolize.

Description
of Center:

Applications must contain three independent research
projects that are equivalent to R01 applications, an administrative and
planning core, and may request one or more facility cores, which support at
least two of the R01 type projects described in the application.

Budget requests must set aside travel support for an annual
program meeting minimally for all project leads associated with the application
and other personnel deemed necessary by the PD(s)/PI(s) . Moreover, each
Administrative Core must set aside $5,000.00 of total budget each year to
support an annual program meeting between Centers and the R01 component of this
program, described in RFA-ES-11-013.

Centers established under this FOA will have in common
support for the following three basic elements: research projects; an
administrative core; and facility cores. For the purpose of this FOA, a Center
for Oceans and Human Health (COHH) is defined as an interdisciplinary
collaborative arrangement among a group of scientists located at the same or
different institutions, committed to conducting at least three individual but
interrelated and interdependent research projects that address the goals of
this FOA. Plans for interaction among the components within Centers must be
explicitly described.

A.
Research Projects

Each Center will minimally support three meritorious
research projects with a conceptual theme focusing on oceans and human health. Research
projects must be interdisciplinary and address one or more of the identified
special emphasis areas including but not limited to: HABs; marine pollution;
statistics/bioinformatics; and the interaction of global climate change with
oceans and human health.

Research projects should unite the skills of basic and
clinical biomedical scientists with physical, chemical, and biological
oceanographic scientists. A Center will be asked to describe a plan for
promotion and support of interdisciplinary planning, implementation and
synthesis of research across and within individual projects. Hypotheses and
specific aims developed and described for research projects must demonstrate
the thematic, interdisciplinary, and collaborative nature of the Center application.
This requirement is meant to promote interdisciplinary collaboration in
development and design of Center research projects as well as continued
collaboration throughout the duration of Center support.

B.
Administrative and Planning Core

The administrative structure should include, in addition to
the Center Director, a Co-Director, a business manager, an internal steering
committee, and an external advisory committee. The Director and Co-Director
should possess complementary expertise in biomedical and oceanographic
sciences. An individual with expertise in either field can be Director or
Co-Director. Both fields should be covered by the Director and Co-Director
team. The external advisory committee (EAC) should consist of a group of three
to five scientists, having expertise appropriate for the Center's research
focus, who are outside the applicant institution. The membership of the
advisory committee must be approved by the Participating Agencies post review.
Names of potential EAC members should not be solicited or submitted in the
application. Please only submit a description of planned committee by
representation based on area of expertise. Individuals in senior leadership
positions should provide intellectual, administrative, and scientific
leadership for the Center and are critical to its overall effectiveness and
evolution. These individuals should be in place and committed to a defined
percent effort.

The administrative core should promote joint planning and
evaluation activities as well as collaborations and interactions among
different components of the Center. The Center must have appropriate and
adequate management capabilities to conduct research and to evaluate the
performance of the Center in achieving the goals of the FOA. Objective
criteria for evaluation, including intermediate markers for assessing the
impact of the science conducted by each Center in elucidating connections
between the oceans and human health, are required as part of this core.

In addition, each Center should describe a mechanism for
data sharing and technology transfer with other Centers and with potential end
users of research results, such as state public health and environment
agencies. It is anticipated that a Center will devote no more than 10 percent
of its budget to the administrative core.

C.
Facility/Service Cores

Centers may support shared core resources common to two or
more research projects. Each Center may support facility cores that provide a
technique, service, or instrumentation to enhance ongoing research efforts.
Examples of such facilities include: biostatistics and/or bioinformatics,
genomics and proteomics, exposure assessment, and sensor development. Budgeted
Center projects as well as research projects external to the Center may have
access to facility cores. The application should provide a total operational
budget for each facility core together with the percentage of support requested
from the Center grant. The application should explain the organization and
proposed mode of operation of each core, including a plan for usage, priority
setting, allocation of resources, and any applicable charge back system. Allocation
among various components of the Center should be balanced and well justified.

Section
II. Award Information

Funding Instrument

Grant

Application Types Allowed

New

The OER
Glossary and the PHS398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

NIEHS and NSF intend to fund an estimate of 3-4 awards,
corresponding to a total of $4.2 million, for FY 2012. Future year amounts
will depend on annual appropriations.

Award Budget

Direct costs are limited to $900,000 per year for a 5-year
period.

Award Project Period

The total project period for an application submitted in
response to this funding opportunity may not exceed 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Section
IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398 Application
Guide.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the PHS398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All page limitations described in the PHS398 Application
Guide and the Table of
Page Limits must be followed, with the following requirements:

Overview of the Program
Project: 12 pages

Research Project
Descriptions:

Research Project Cover
Page: 1 page

Research Project
Summary: 1 page

Research Project
Specific Aims: 1 page

Research Strategy: 12
pages

Core Descriptions:

Core Unit Cover Page: 1
page

Core Unit Summary: 1
page

Core Unit Specific
Aims: 1 page

Core Unit Structure,
Administration & Services: 6 pages

Description

Follow instructions in the PHS 398 Application Guide, and
note the following additional instructions.

The program project grant application should be
structured as a series of separate but interrelated project proposals. State
the proposed program’s broad, long-term objectives, specific aims, and the
significance to the mission of NIEHS. Define the relevance of each proposed
project and shared resource core to the overall theme and goals of the program.

Detailed Budget for Initial Budget Period

Follow instructions in
the PHS 398 Application Guide, and note the following additional instructions.

Use PHS-398 Form Page, "DETAILED BUDGET FOR INITIAL
BUDGET PERIOD," to present the total budget for all requested support for
the first year. For each category, such as "Personnel,"
"Equipment," etc., give the amount requested for each Research Project
component and each Core unit, with subtotals.

If consortium arrangements involving other institutions
or organizations are anticipated, include total (direct and indirect) costs
associated with such third-party participation in the Consortium/Contractual
Costs category. Costs for purchased services should be itemized under the
"Other Expenses" category.

Budget for Entire Proposed Period of Support

Follow instructions in the PHS 398 Application Guide, and
note the following additional instructions.

Use PHS-398 Form Page, "BUDGET FOR ENTIRE PROPOSED
PROJECT PERIOD," to prepare a budget, by category, that provides totals
for each year of requested support. Requests for any increases in succeeding
years must be justified in the individual Research Project component and Core
unit budgets.

Budgets for Individual Research Project Components and
Core Components

Prepare “Detailed
Budget for Initial Budget Period” for each component.

Prepare “Budget for
Entire Proposed Period of Support” for each component.

Budget Justifications and Explanations

Describe the specific functions of all key personnel,
consultants, collaborators, and support staff. For all years, explain and
justify any unusual items such as major equipment or alterations and
renovations.

Biographical Sketch

Follow instructions in the PHS 398 Application Guide, and
note the following additional instructions.

Biographical sketches are required for all key personnel
participating in the Research Project components and Core units. Compile all
biographical sketches starting with the overall program project leader followed
by all other investigators, including the individual project/ core leaders, in
alphabetical order. Do not repeat biographical sketches in the individual
research projects or shared resources cores.

Resources

Follow instructions in the PHS 398 Application Guide, and
note the following additional instructions.

Complete the "Resources" page of PHS-398 for
the overall project. Briefly describe the features of the institutional
environment that are or would be relevant to the effective implementation of
the proposed program. As appropriate, describe available resources, such as
clinical and laboratory facilities, participating and affiliated units, patient
populations, geographical distribution of space and personnel, and consultative
resources.

Project overview

Each P01 program project application must include a
minimum of three individual (albeit connected) research projects each of which
is pertinent to the central goal of the program. If support of core resources
is requested, a separate component describing and justifying these should be
included.

Research
Projects

The
Research Projects should include:

Cover page.

Project Summary

Project Specific Aims

An overall research
strategy section for the project

Any justification for
human and animal experimentation.

Each individual project of a program project grant should
represent both a separate and an interdependent research effort. Each research
project should be prepared according to the application guide instructions. The
overall format and page limits for an R01 application apply to each of the
component projects. The special benefits associated with being part of the
program project must also be addressed. Do not repeat the individual budget
pages and biosketches.

Instead of the standard PHS 398 face page for each
project, create a title page for the project that lists the project name and
the name of the project director.

Specific Aims

Specific aims should
be built around serving the goals of the program project.

Research Strategy

Approach. The
special benefits associated with being part of the program project and the
relationship of this project to the other projects and cores should be
addressed.

Research Plan

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions:

Resource Sharing Plan

Individuals are
required to comply with the instructions for the Resource Sharing Plans (Data
Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies
(GWAS)) as provided in the PHS398 Application Guide, with the following
modifications:

All applications, regardless
of the amount of direct costs requested for any one year, are expected to
address a Data Sharing Plan.

Software Sharing Plan:
A software dissemination plan, with appropriate timelines, is expected in
the application only if software development is a part of the application.
Software sharing plans should be included with the Resource Sharing Plan.
There is no prescribed single license for software produced through grants
responding to this announcement. However, NIH does have goals for software
dissemination, and reviewers may comment on the dissemination plan
relative to these goals:

The software should be
freely available to biomedical researchers and educators in the
non-profit sector, such as institutions of education, research
institutions, and government laboratories.

The terms of software
availability should permit the dissemination and commercialization of
enhanced or customized versions of the software, or incorporation of the
software or pieces of it into other software packages.

To preserve utility to
the community, the software should be transferable such that another
individual or team can continue development in the event that the
original investigators are unwilling or unable to do so.

The terms of software
availability should include the ability of researchers to modify the
source code and to share modifications with other colleagues. An
applicant should take responsibility for creating the original and
subsequent “official” versions of a piece of software.

To further enhance the
potential impact of their software, applicants are expected to propose a
plan to manage and disseminate the improvements or customizations of
their tools and resources by others. This proposal may include a plan to
incorporate the enhancements into the “official” core software, may
involve the creation of an infrastructure for plug-ins, or may describe
some other solution.

The plan for software
sharing may be commented on during peer review with any other resource sharing
plans.

The adequacy of the
software sharing plans will be considered by program staff when making
recommendations about funding applications as appropriate. In making such
considerations, prior to funding, program staff may negotiate modifications of
software sharing plans with the Principal Investigator(s). Any software
dissemination plans represent a commitment by the institution (and its
subcontractors as applicable) to support and abide by the plan.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS398 Application Guide.

Foreign Institutions

Foreign (non-US) Institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions
described throughout the PHS398 Application Guide.

Applications must be received on or before the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by the
National Science Foundation and the National Institute of Environmental Health
Sciences, NIH. Applications that are incomplete and/or nonresponsive will not
be reviewed.

Each Center must budget $5,000.00 per year to support annual
OHH meetings in venues to be determined. These funds will be used to support
costs associated with logistics of the annual OHH meeting, including facilities
necessary for hosting the meeting and traveling outside speakers. Additionally,
centers will be responsible for the support of traveling key personel to the
annual OHH meetings.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of
the following review criteria and additional review criteria (as applicable for
the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD(s)/PI(s), do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Administrative
and Planning Core

What is the decision-making process within the
proposed Center? Is it adequate for the evaluation of research productivity,
allocation of funds, and management of the resources? Are procedures clearly
outlined to measure and track Center goals, outputs and outcomes?

How will the Administrative Core promote joint
planning and evaluation activities as well as collaborations and interactions
among different Research Projects of the Centers? What are the academic
environment and resources in which the research will be conducted? Are there
available and appropriate space, equipment, human subjects, animals, or other
resources as required for potential interaction with scientist(s) from other
departments to complete the scope of work as proposed?

What is the institutional commitment to the Center,
including fiscal responsibility and management capability of the institution to
assist the Program Director(s)/ Principal Investigator(s) and his/her staff in
following DHHS, PHS, NIH and NSF policy?

Facility/Service
Cores

What is the Core's utility to Center investigators?
Does each Core provide services for two or more research projects that are
judged to have substantial merit? What is the quality of the facility or
services provided? What are the availability and/or adequacy of the physical
space, laboratory, clinic and/or equipment proposed for the Core? What is the
cost-effectiveness of the service provided? Are the qualifications of the
personnel involved, their experience, and commitment to the Core appropriate?

Overall
Center

Does the Center consist of a cohesive and
multidisciplinary focus? Does a coordinated interrelationship exist between
the research projects and cores? Are the components of the Center related to
the common theme of the Center? What is the scientific gain of combining the
component parts into a Center? For new applications, is there evidence of the
degree of synergy (degree of interaction, collaborative research opportunities)
that will be stimulated by the Center? How do the research projects and cores
relate to the central theme and the ability of the Center to meet its long range
goals? Will the specific scientific objectives of each project benefit
significantly from, or depend upon collaborative interactions with other
projects in the program (i.e., objectives that can be uniquely accomplished,
specific contributions to the accomplishments of objectives in other projects,
objectives that can be accomplished with greater effectiveness and/or economy
of effort)? Have the investigators adequately conceptualized the Center’s
expected results and potential benefits to the broader public?

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of
minorities and members of both genders, as well as the inclusion of children. For
additional information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NIEHS , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall
impact/priority score.

Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all
other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of
review by the National Advisory Environmental Health Sciences Council.. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.